| Deflated balloon prior to 6
months | A deflated balloon can pass through the intestines naturally
or it can become stuck and have to be removed with
surgery. If not treated, it can cause death | Was not reported in the U.S. study |
| Did not understand or remember
instructions and warning
statements about taking acid
reducing medications | Ulcers (sores in the stomach), stomach pain and/or
burning, and heartburn. If not treated may lead to a hole in
the stomach, which can cause death. | Was not reported in the U.S. study. |
| Hole forming all the way through
the stomach, caused by the
endoscope or other reasons | Ulceration and the endoscope may not be the only
causes of a hole forming in the stomach. Other causes
are currently not well-understood. If not treated, it can
lead to death. | Was reported once in the U.S. study (0.006%) (1 case per
160 patients)
US rate for hole forming in the stomach is 0.064%* (about
6 cases per 10,000 patients)
Global rate for hole forming in the stomach is 0.01%*
(about 1 case per 10,000 cases) |
| Did not understand or remember
instructions and warning
statements about use longer
than 6 months | Leaving the balloon in for longer than 6 months can lead to
a deflated balloon. A deflated balloon can pass through the
intestines naturally or it can become stuck and may have to
be removed with surgery. If not treated, it can lead to death | Was not reported in the U.S. study. |
| A hole forming all the way
through the esophagus, caused
by the endoscope or other
instruments | Bleeding, pain, infection, surgery to repair injury. If not
treated, it can lead to death | Was not reported in U.S. study
US rate for a hole forming in the esophagus is 0.029%*
(less than 3 cases per 10,000 patients)
Global rate for hole forming in the esophagus is <0.01%*
(less than 1 case per 10,000 patients) |
| Heart problems, or heart attack
during anesthesia | Chest pain, fast or slow heartbeat, and a hard time
breathing. If not treated, it can lead to death | Was not reported in the U.S. study |
| Allergic reaction to medications,
including anesthesia | Rash, hives, wheezing, hard time breathing, sudden drop
in blood pressure, sweating, fast heartbeat, and swelling
around the mouth, throat, or eyes. Severe allergic reactions
can lead to death if not treated right away | Was not reported in the U.S. study |
| Compression of the Pancreas | Severe persistent stomach pain / back pain with nausea or
vomiting that may be caused by irritation of or injury to the
pancreas | Was not reported in U.S. study
US rate for pancreatitis is is 0.043%* (about 4 cases per
10,000 patients)
Global rate for pancreatitis is <0.01%* (less than 1 case per
10,000 patients) |
| Over inflated balloon | The balloon could over inflate with gas or fluid by itself while
it is in a patient’s stomach. The balloon will need to be
removed early. | Was not reported in the U.S. study
US rate for over inflated balloon is 0.314%* (about 3 cases
per 1,000 patients)
Global rate for over inflated balloon is 0.07%* (about 7
cases per 10,000 patients) |
| Death | N/A | Was not reported in the U.S. study
US mortality rate is 0.036%* (less than 4 deaths per 10,000
patients)
Global mortality rate is <0.01%* (less than 1 death per
10,000 patients) |
| Did not understand or remember
instructions and warning
statements about not eating for
48 hours before removal and
not drinking for 12 hours before
removal or experiencing severely
delayed gastric emptying | If food and liquid are retained in the stomach during
removal, there is an increased risk of these stomach
contents entering the lungs | Was not reported in the U.S. study
US rate for aspiration is 0.029%* (less than 3 cases per
10,000 patients)
Global rate for aspiration is <0.01%* (less than 1 case per
10,000 patients) |
